Dyanavel XR

(amphetamine ER) 

 

 

 

 Full Prescribing Information 

 DailyMed Drug Information 

 

 

 

 

 Forms/Strengths 

 

 Tablets: 5 mg, 10 mg, 15 mg, and 20 mg 

 Liquid: 2.5 mg/mL (Total Bottle: 464 mL) 

 

 

 Dosing 

 

 Age: ≥ 6 y/o 

 Onset: ~60 min 

 Duration: up to 13 hours 

 Considerations: May be taken with or without food. Liquid and tablet formulations are interchangeable.

 

 Tablet: The 5mg dose is scored to allow for accurate dosing down to 2.5mg. 

 Liquid:  Bubblegum flavor 

 

 

 Initial Dose: 

 

 6-12 y/o: 2.5-5 mg 

 13+ y/o: 5-10 mg 

 

 

 Titration: 

 

 6-12 y/o: 2.5 mg every 4-7 days 

 13+ y/o: 5 mg every 4-7 days 

 

 

 Max Dose: 20 mg 

 

 

 Quick Facts 

 

 Increases synaptic dopamine and norepinephrine; improves focus, attention, and impulse control 

 Extended-release oral suspension; liquid formulation for ease of administration 

 Unique delivery system provides consistent, sustained symptom control 

 Common side effects: decreased appetite, insomnia, increased heart rate, elevated blood pressure 

 

 

 Indications 

 

   ADHD (ICD-10: F90.0) 

 

 

 Off-Label Uses 

 

 N/A  

 

 

 How to Take 

 

 Take once daily in the morning to reduce the risk of insomnia. 

 Can be taken with or without food . 

 Shake the suspension well before each dose to ensure even distribution. 

 Measure dose accurately using a provided oral syringe or dosing cup—do not use household spoons. 

 

 

 Side Effects 

 

   

 

 

 Monitoring / Labs 

 

 Cardiovascular : Baseline and routine monitoring of heart rate and blood pressure. 

 Growth in Pediatrics : Regular monitoring of height and weight to detect growth suppression. 

 Psychiatric Symptoms : Observe for mood changes, anxiety, or psychosis. 

 Abuse Potential : Monitor for misuse or diversion. 

 

 

 Education 

 

 

 When to Call the Doctor: 

 

 Severe mood changes, aggression, or suicidal thoughts . 

 Chest pain, rapid heartbeat, shortness of breath ( cardiovascular concerns ). 

 Uncontrolled movements, tics, or worsening anxiety. 

 Numbness, coldness, or color changes in fingers or toes ( circulatory issues ). 

 Unexplained weight loss or delayed growth in pediatric patients . 

 

 

 

 Safety Tips: 

 

 Monitor blood pressure and heart rate , especially in patients with cardiovascular risk. 

 Use caution in patients with anxiety, bipolar disorder, or psychosis , as symptoms may worsen. 

 Avoid caffeine and other stimulants , which may amplify side effects. 

 Ensure adequate hydration and nutrition , as appetite suppression is common. 

 Tapering may be required if discontinuing after long-term use. 

 

 

 

 Parent Tips for Pediatric Patients: 

 

 Encourage a nutrient-dense diet to counteract appetite suppression. 

 Administer in the morning before school for optimal effect. 

 Monitor school performance and behavioral changes . 

 Observe for sleep disturbances ; adjust timing if necessary. 

 Communicate regularly with teachers and caregivers about medication effects. 

 

 

 

 

 Additional Information 

 

 

 Contraindications: 

 

 Hypersensitivity to amphetamines or formulation components. 

 Use within 14 days of MAOI therapy (risk of hypertensive crisis). 

 Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma . 

 History of substance use disorder , unless benefits outweigh risks. 

 

 

 

 Pregnancy: 

 

 Category C ; use only if benefits outweigh risks. 

 May cause neonatal withdrawal symptoms or low birth weight . 

 

 

 

 Lactation: 

 

 Excreted in breast milk ; not recommended due to potential infant exposure. 

 

 

 

 Drug Interactions: 

 

 Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk . 

 Acidifying agents (e.g., ascorbic acid) may reduce drug absorption. 

 Alkalinizing agents (e.g., sodium bicarbonate) may increase amphetamine levels. 

 May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).